Clinical Trials Assistant
il y a 2 semaines
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.
The **Clinical Trials Assistant **assists in the delivery of Clinical Development objectives and achieve Clinical Operation Excellence, mainly by supporting the Clinical Research Manager (CRM)/Clinical Project Manager (CPM) in administrative activities within the conduct of the clinical studies.
And also performs and/or coordinates, on request, some non-administrative specific clinical study tasks under the direction of the CRM/CPM and Program Director/Head of ClinOps.
**Main Responsibilities**:
**Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)**
- In charge of the Ipsen electronic TMF (and/or paper TMF, if applicable) set-up and administration.
- Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
**B**e responsible for follow
- up and review of financial documents, in collaboration with CRM/CPM**
- Create and update financial information within the Ipsen financial system (K2, SAP,) (Internal Order, Purchase Order, goods receipt & invoices), or managed by a dedicated position, if available.
- Create and follow-up of the clinical study Commitment Requests within the Ipsen dedicated tool (K2).
**Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)**
- Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect).
- Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
**Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)**
- Coordinate and conduct in-house and external clinical operations activities
- Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes.
- Coordinate the writing of articles related to the clinical study or working groups to be posted in the monthly newsletter.
**English is a must have.**
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